Felix S.

I specialize in supporting Life Science Organizations and their investors to achieve sustainable entrepreneurial success through tailored compliance, legal, and organizational solutions.

• AI Governance & Compliance:

Advising organizations on EU AI Act implementation, AI risk classification, and alignment with internal approval and co-determination processes (BetrVG) for compliant AI deployment

• Establishing Research & Commercial Organizations: Building structures aligned with local legal requirements and industry standards.

• Equipping Teams: Developing contract templates, policies, SOPs, and workflows customized to legislation, EFPIA, and local industry codes.

• Training & Process Optimization: Training staff and optimizing processes using innovative tools, including AI-driven solutions like RAGs.

• Daily Compliance & Transparency Support: Assisting teams with compliance operations, including Sunshine Act reporting for HCPs, HCOs, and Patient Organizations, with proven IT tool implementation.

• Interim Leadership: Serving as an interim compliance officer or in temporary leadership roles.

• Project Support: Delivering expertise for product launches, market access preparation, M&A, and restructuring initiatives.

• Investigations & Audits: Conducting internal investigations, audits, and risk assessments to ensure compliance.

• ESG Governance: Establishing governance structures to achieve strong ESG ratings and sustainable operations.

• M&A Compliance in Life Sciences: Support compliance and legal due diligence for M&A projects, including post-acquisition monitoring to protect investor assets and ensure regulatory alignment.